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Trial registered on ANZCTR


Registration number
ACTRN12608000364370
Ethics application status
Approved
Date submitted
19/06/2008
Date registered
25/07/2008
Date last updated
24/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhanced Influenza Vaccines in Chronic Disease Study
Scientific title
Randomized, controlled Phase 1/2 study to evaluate the safety and effectiveness of an enhanced potency adjuvanted seasonal influenza vaccine in patients with chronic disease and the elderly
Secondary ID [1] 591 0
FLU002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart disease 3278 0
Chronic Obstructive Pulmonary Disease 3279 0
Diabetes Mellitus 3280 0
Chronic renal disease 3281 0
Old age 3282 0
Condition category
Condition code
Cardiovascular 3443 3443 0 0
Diseases of the vasculature and circulation including the lymphatic system
Respiratory 3444 3444 0 0
Asthma
Public Health 3445 3445 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose of Advax-adjuvanted (20 miligram) seasonal 2008 trivalent inactivated influenza vaccination (total 45 micrograms of haemagglutinin) given once only by intramuscular injection
Intervention code [1] 3019 0
Prevention
Intervention code [2] 3020 0
Treatment: Other
Comparator / control treatment
Single dose of seasonal 2008 trivalent inactivated influenza vaccination (total 45 micrograms of haemagglutinin) given once only by intramuscular injection
Control group
Active

Outcomes
Primary outcome [1] 4336 0
Immunogenicity as assessed by haemagglutination inhibition assay (HAI)
Timepoint [1] 4336 0
3-4 weeks post vaccination
Primary outcome [2] 4337 0
Safety as assessed by local (e.g. injection site reactions including pain, swelling, erythema) and systemic adverse events (e.g. fever, nausea, myalgia) as recorded in subject diaries and routine biochemical and haematological screening assays
Timepoint [2] 4337 0
3 weeks post vaccination
Secondary outcome [1] 7309 0
Influenza-related morbidity as assessed by incidence of respiratory infections, hospitalisations and unscheduled general practitioner or emergency department visits need for antibiotic therapy.
Timepoint [1] 7309 0
3, 6, and 12 months post vaccination

Eligibility
Key inclusion criteria
Diagnosis of chronic obstructive pulmonary disease, diabetes mellitus, cardiovascular disease or chronic renal disease or age 60 years or greater
Minimum age
20 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of vaccination with current (2008) season influenza vaccine, History of vaccine or egg allergy, Women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device or mechanical barrier device, Pregnant or lactating women, Concurrent immunosuppressive therapy, including corticosteroids (with the exception of topically applied/inhaled steroids), Individuals with a known infection of human immunodeficiency virus (HIV), History of intravenous drug abuse or alcohol abuse

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3493 0
Commercial sector/Industry
Name [1] 3493 0
Vaxine Pty Ltd
Address [1] 3493 0
Flinders Medical Centre
Adelaide 5042
Country [1] 3493 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxine pty Ltd
Address
Flinders Medical Centre
Adelaide 5042
Country
Australia
Secondary sponsor category [1] 3136 0
None
Name [1] 3136 0
Address [1] 3136 0
Country [1] 3136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5530 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 5530 0
Flinders Medical Centre
Adelaide 5042
Ethics committee country [1] 5530 0
Australia
Date submitted for ethics approval [1] 5530 0
Approval date [1] 5530 0
Ethics approval number [1] 5530 0

Summary
Brief summary
This study seeks to determine whether the effectiveness of current flu vaccines in protecting people with chronic disease against flu-complications can be improved by addition of a specific compound (adjuvant) which acts by boosting the immune response to the vaccine
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28677 0
Address 28677 0
Country 28677 0
Phone 28677 0
Fax 28677 0
Email 28677 0
Contact person for public queries
Name 11834 0
Dr Dimitar Sajkov
Address 11834 0
Flinders Medical Centre
Adelaide 5042
Country 11834 0
Australia
Phone 11834 0
0882044572
Fax 11834 0
Email 11834 0
dimitar.sajkov@fmc.sa.gov.au
Contact person for scientific queries
Name 2762 0
Professor Nikolai Petrovsky
Address 2762 0
Flinders Medical Centre
Adelaide 5042
Country 2762 0
Australia
Phone 2762 0
0882044572
Fax 2762 0
Email 2762 0
nikolai.petrovsky@flinders.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary